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Comparison of general anaesthesia versus regional anaesthesia with sedation in selected maxillofacial surgery: a randomized controlled trial
Journal of Cranio-Maxillo-Facial Surgery 42 (2014) 250e254
Contents lists available at SciVerse ScienceDirect
Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com
Comparison of general anaesthesia versus regional anaesthesia with sedation in selected maxillofacial surgery: a randomized controlled trial Amit Rastogi a, Prakhar Gyanesh b, *, Surbhi Nisha c, Appurva Agarwal d, Priya Mishra e, Akhilesh Kumar Tiwari a a
SGPGI, Lucknow, India Global Hospital, Chennai, India Sardar Patel Institute of Medical and Dental Sciences, Lucknow, India d GSVM Medical College, Kanpur, India e Shine Dental Clinic, Lucknow, India b c
a r t i c l e i n f o
a b s t r a c t
Article history: Paper received 2 September 2012 Accepted 7 May 2013
Background: The airway is the foremost challenge in maxillofacial surgery. The major concerns are difficulty in managing the patient’s airway and sharing it between the anaesthetist and surgeons. General anaesthesia, with endotracheal intubation, is the commonly used technique for maxillofacial procedures. We assessed the efficacy and safety of a regional block with sedation technique in certain maxillofacial operations, specifically temporomandibular joint (TMJ) ankylosis and mandibular fracture cases, and compared it with conventional general anaesthesia. We compared the time to discharge from the post anaesthesia care unit (PACU) and the occurrence of side effects, as well as surgeon and patient satisfaction with the anaesthetic technique, between the two groups. Materials & Methods: We enrolled 50 patients of ASA grade 1 or 2, aged 15e50 years, scheduled for maxillofacial surgery (mandibular fracture or TMJ ankylosis). The patients were divided into two groups of 25 each, to receive sedation with a regional block with the use of a peripheral nerve stimulator in group I and general anaesthesia in group II. We observed haemodynamic parameters, intraoperative and postoperative complications and the amount of surgical bleeding in the two groups. Total anaesthesia time, patient and surgeon satisfaction, time to rescue analgesia, the number of rescue doses required, and the time to discharge from the PACU were compared. Results: The groups were comparable with respect to demographic profile, intraoperative haemodynamic parameters, surgical time, and amount of blood loss. Postoperative pain was assessed using the visual analogue score (VAS). Patients in group I had lower VAS scores after surgery and remained pain-free for longer than those in group II. The mean pain-free interval in group I was 159.12 43.95 min and in group II was 60.36 19.77 min (p < 0.005). Patients in group I required lower doses of rescue analgesia than those undergoing the surgery under general anaesthesia (p < 0.005). Patients receiving regional blocks also had fewer episodes of postoperative nausea and vomiting (p ¼ 0.005). These results led to earlier discharge of patients in group I from the PACU. Conclusions: Regional block with sedation is a safe alternative technique for patients undergoing surgery for mandible fracture or TMJ ankylosis, with clear advantages over general anaesthesia. Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Keywords: Regional anaesthesia Maxillofacial surgery sedation General anaesthesia Peripheral nerve stimulator
1. Introduction
* Corresponding author. Flat No F14, Casa Grande Riveria, Medavakkam, Chennai, India. Tel.: þ91 8874869249; fax: þ91 5224075803. E-mail addresses: [email protected], [email protected] (P. Gyanesh).
Mandibular fractures and temporomandibular joint (TMJ) ankylosis require special attention to the patient’s airway. These patients frequently present with difficulty in ventilation and intubation. Moreover, anaesthetists and surgeons have to share the patient’s airway during surgery (Vas and Sawant, 2001; Raval and
1010-5182/$ e see front matter Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jcms.2013.05.010
A. Rastogi et al. / Journal of Cranio-Maxillo-Facial Surgery 42 (2014) 250e254
Rashiduddin, 2011). General anaesthesia is the conventional way of managing these patients. This involves exposing the patients to the stress of ’awake’ airway manipulation and has its own set of postoperative problems (Batra and Mathew, 2005). Previous reports showed that surgery for TMJ ankylosis and mandibular fractures under regional anaesthesia can be safe and effective (Walz et al, 1996; Gajiwala, 2008). To our knowledge, no reported study has compared the efficacy and safety of general anaesthesia and regional anaesthesia with sedation in these cases. We propose that regional anaesthesia techniques may provide better postoperative analgesia, along with a decreased incidence of side effects, and thus earlier discharge from the postoperative care unit (PACU), than the use of general anaesthesia, in patients undergoing surgery for mandibular fractures or TMJ ankylosis. 2. Patients and Methods After approval from the institutional ethics committee, 50 patients between the ages of 15 and 50 years, undergoing surgery for mandibular fracture or TMJ ankylosis, were randomly allocated using computer-generated random numbers to two groups: Group I (regional block with sedation) and group II (general anaesthesia with endotracheal intubation), for the prospective study. Patients with an allergy to local anaesthetics, coagulation dysfunction, and ASA grade 3 were excluded. We also excluded patients with other traumatic fractures in addition to mandibular fractures, fractures of bilateral parasymphysis or condyle of the mandible and patients with significant obstructive sleep apnoea (OSA), who might have difficulty maintaining their airway in a supine position. We explained the entire procedure to the patient, and obtained their written consent. Patients in both the groups were uniformly premedicated with injection midazolam (0.03 mg/kg) and injection glycopyrrolate (0.004 mg/kg) intravenously. Preoperatively, both the groups received dexamethasone I.V. (0.08 mg/kg) to prevent airway oedema. Monitoring included five lead ECG, pulse oximetry, capnography, temperature and non-invasive blood pressure. We kept the difficult airway cart ready at all times. Once the patient was moved into the operating room (OR), baseline vital signs such as blood pressure, pulse rate, body temperature and oxygen saturation were recorded and induction was started according to the patient’s allotted group. We recorded the total time taken to induce the patient at the start of the procedure and the complete surgical time, and compared them between the groups. 2.1. Group I Patients in group I received mandibular and maxillary nerves blocks, with a solution made up of 14 ml of 0.5% bupivacaine, diluted in normal saline. The preauricular region was first infiltrated with 2 ml of the solution. The mandibular nerve was blocked by the coronoid approach, identifying the coronoid notch on the side of the block by opening or closing the mouth or by locating midpoint of the zygomatic process. A StimuplexR A (B.Braun Medical Pvt Ltd), 22G (50 mm) needle was inserted perpendicular to the median sagittal plane until it contacted the lateral pterygoid plate. It was then withdrawn slightly and reinserted, so that it moved inferiorly and posteriorly. After elicitation of paraesthesia and observing contractions of the masseter muscle with current value as low as 0.5 mA with StimuplexR HNS 12 (B.Braun Medical Pvt Ltd) nerve stimulator, 3e5 ml of the drug solution was injected with intermittent negative aspiration. The temporal region, auricle, external auditory meatus, TMJ, salivary glands, floor of the mouth, anterior two-thirds of the tongue, mandible, lower teeth, gingiva, buccal mucosa, and the inferior portion of the face was anesthetized following the injection.
251
The needle was then withdrawn back to the level of the lateral pterygoid plate, directed superiorly and anteriorly, and advanced for 0.5e1 cm, until the development of paraesthesia over the maxillary nerve. Then, 5e10 ml of the local anaesthetic solution was injected to block the maxillary nerve. Use of the peripheral nerve stimulator allowed us to block the mandibular nerve with precision and after sedating the patient, thus providing greater patient comfort. The surgeon infiltrated the line of the incision with 2% adrenalized lignocaine solution (5e10 ml). After a bolus of propofol (40 mg if <60 kg or 60 mg if >60 kg), propofol infusion was started at the rate of 50 mg/kg/min and titrated to achieve and maintain a Modified Observer’s Assessment of Alertness/Sedation Scale (MOAA/S) of 2. A nasopharyngeal airway (number 8 for males and 7 for females) was inserted in one nostril, after proper lubrication with lignocaine jelly. An FG 8 catheter was inserted through the airway and connected to an oxygen source for insufflation with humidified oxygen. Surgery was started after confirming satisfactory surgical anaesthesia. In case of block failure, we planned to proceed as per the anaesthesia protocol for group II, and to exclude the patient from the study. Patients were moved to the PACU after surgery. 2.2. Group II Patients in this group received general anaesthesia with nasotracheal intubation. We assessed their airway preoperatively and decided on the technique of airway access. Patients with a mandibular fracture have trismus due to pain and generally have some mouth opening after induction of anaesthesia. In these patients, anaesthesia was induced with injection propofol (2.0 mg/kg), injection fentanyl (4 mg/kg). Considering the difficult airway in these patients, we used injection succinylcholine (1.5 mg/kg) to facilitate nasotracheal intubation. All patients with TMJ ankylosis underwent fiberoptic intubation while awake. The procedure was explained to them at the preanaesthetic check-up, and any anxiety was allayed. Airway anaesthesia for these patients was provided with lignocaine jelly and gargles, and transtracheal block, along with ‘spray as you go’ technique. Anaesthesia and muscle relaxation were maintained with intravenous propofol (50e150 mg/kg/minute) and vecuronium (0.1 mg/kg bolus followed by 1 mg every 30 min) and the patients’ lungs were ventilated with an oxygen-air mixture (1:1). All patients were extubated after reversal with neostigmine (0.05 mg/kg) and glycopyrrolate (0.01 mg/kg), using standard criteria of reversal (sustained head lift for 5 s and sustained handgrip for 5 s along with adequate spontaneous respiration). Patients were then moved to the PACU. Intramuscular diclofenac (75 mg) was given to both groups at the time of skin closure for postoperative analgesia. The severity of postoperative pain was measured and recorded using a 10-cm Visual Analogue Scale (VAS) score, where 0 ¼ no pain and 10 ¼ the worst imaginable pain. Intravenous paracetamol 1 g was used as rescue analgesia in the PACU if the VAS score was more than 3. Injection of tramadol (1.5 mg/kg intravenously) was given if the patients required another rescue before 4 h after paracetamol. All patients were studied for 24 h for the level of analgesia and the incidence of postoperative nausea and vomiting (PONV) and sore throat. Patients were monitored every 15 min in the PACU and every 4 h for the next 24 h in the ward. The Post Anaesthesia Discharge scoring System (PADSS score) was assessed by a doctor in the PACU and patients were moved when the PADDS score became >9. The length of PACU stay was recorded. We studied 25 patients in each group, which achieved a power of 80% for a difference of 30 min in the PACU length of stay at a
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A. Rastogi et al. / Journal of Cranio-Maxillo-Facial Surgery 42 (2014) 250e254
significance level of 0.05. All results were analysed using SPSS 16 software. A p value of <0.05 was taken as significant with Bonferroni correction of the alpha value for multiple corrections. Demographic data were compared using the Chi-square test for categorical variables. Student t-test was used to compare the means of the two groups to assess the statistical significance of the difference in duration of PACU stay, the time until first rescue analgesia, and the number of rescue doses demanded. Incidence of sore throat and PONV was analysed using the Chi-square test while surgeon and patient satisfaction was analysed using the Kruskal Wallis test for non-parametric variables. 3. Results We evaluated 80 patients for enrolment in this study; 20 patients did not give consent, and were excluded and 10 patients suffering from multiple facial fractures and were also excluded. In total, 50 patients were enrolled and divided into groups by block randomization. The two groups were comparable with regard to surgery performed and demographic parameters (Table 1). Patients with mandible fractures underwent open reduction and internal fixation. Patients with TMJ ankylosis underwent gap arthroplasty or inferiorly based temporalis fascia or muscle fascia interpositional arthroplasty. There were no airway incidents in either group. There was no case of block failure. Both groups had comparable haemodynamic status, preoperatively and intraoperatively. There was less blood loss in the regional anaesthesia group, but this was not statistically significant (Table 2).
Table 3 Number of rescue analgesics required in the next 24 h.
Table 1 Type of surgery and demographic distribution. Group I Surgery (TMJ/Mand) Sex (M/F) Age (Mean S.D.) Weight (kg)
11/14 20/5 33.6 5.84 63.86 3.29
Total anaesthesia time was measured from the time the patient was taken into the OR until the patient was moved out of the OR. The anaesthesia time was significantly less in the regional group. The surgical times in the two groups were similar (Fig. 1). Postoperatively, the patients who received sedation and blocks remained more comfortable than those receiving general anaesthesia. They had better pain relief, suffered from fewer episodes of PONV and sore throat, and were discharged from the PACU earlier than those in the general anaesthesia group. We gave rescue analgesia to patients with a VAS score >3 in the postoperative period and noted the time until the first dose of the rescue analgesia. Patients receiving blocks had lower VAS scores in the postoperative period and remained pain-free for longer. There was a significant difference in the time to rescue analgesia between the two groups. The mean pain-free interval in group I was 159.12 min with a standard deviation of 43.95, while in group II it was 60.36 min with a standard deviation of 19.77 (p ¼ 0.001). We recorded and compared the number of rescue analgesia required by patients in the next 24 h. Patients receiving regional anaesthesia required fewer rescue analgesics; the difference was statistically significant (Table 3). Seven patients (28%) receiving general anaesthesia had a sore throat postoperatively, whereas none did in the other group. The incidence of PONV was also higher in those receiving general anaesthesia. There were 8 patients (32%) in group II with PONV whereas only a single patient in group I suffered from it. Both these parameters differed significantly between the two groups (Fig. 2). Patients were observed for 4 h for postoperative sedation using the MOAA/S scale. In group I, patients had excellent recovery from
Group II 8/17 18/7 32.16 4.13 59.56 4.63
p value .561 .742 .341 .156
Group I Group II
No. of rescue analgesics
p value
3.32 .557 5.92 .971
<.005
Table 2 Amount of surgical blood loss (ml) between groups.
Group I Group II
Amount of blood loss
p value
356 124.43 364 127.08
0.756
Fig. 2. Incidence of PONV and sore throat.
Fig. 1. Total surgical, anaesthesia and time taken to induce the patient.
Fig. 3. MOAA/S scoring in group I and group II in the postoperative period.
A. Rastogi et al. / Journal of Cranio-Maxillo-Facial Surgery 42 (2014) 250e254
sedation and after 30 min, patients were cooperative and welloriented. The two groups showed statistically significant difference in sedation level until 60 min after surgery (Fig. 3). Patients were discharged from the PACU based on the PADSS score. We measured the time to discharge from the PACU between the two groups and found it to be significantly different. The length of PACU stay was 35 7.1 min in the regional group while it was 93.80 12.5 min in the general anaesthesia group (p ¼ 0.004; Fig. 4). Patient and surgeon satisfaction were assessed postoperatively with the help of a four-grade questionnaire (poor, average, good, excellent). Patients in group I were comparatively more satisfied because they had an early discharge from the PACU and there was a very low incidence of PONV. However, there was no statistically significant difference when surgeon satisfaction was taken into account (Table 4). 4. Discussion We found that in patients undergoing surgery for mandible fracture or TMJ ankylosis, regional anaesthesia provided better postoperative pain relief than general anaesthesia, with lower incidences of PONV and sore throat. Patient satisfaction was also higher with regional anaesthesia than with general anaesthesia. Regional anaesthesia significantly reduced the time to discharge from the PACU, as assessed using PADSS score. The chief concern, when providing anaesthesia to patients undergoing orthognathic surgery, is the means of securing and maintaining each patient’s airway. While patients with a mandibular fracture have decreased mouth opening due to trismus, they may also have their maxilla and mandible wired together in the postoperative period (van den Bergh et al, 2012). TMJ ankylosis leads to facial deformity with retrognathia and these patients are difficult to ventilate and to intubate. Patients with TMJ ankylosis frequently have associated obstructive sleep apnoea (OSA), have difficulty in maintaining their airway when in a supine position, and are very sensitive to central depressant drugs used in general anaesthesia (Vas and Sawant, 2001; Gundlach, 2010; Raval and Rashiduddin, 2011). These patients should be extubated when they are fully awake, at the end of the procedure, and are prone to post-surgery desaturation (Boushra, 1996; Shah et al., 2002).
Fig. 4. Time to PACU discharge (minutes).
Table 4 Comparison of patient and surgeons’ satisfaction.
Patient satisfaction Surgeon satisfaction
Group Group Group Group
I II I II
Poor
Average
Good
Excellent
p value
0 0 0 0
1 3 1 1
10 15 12 13
14 7 12 11
0.03 0.79
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General anaesthesia with nasotracheal intubation is commonly used to anaesthetize patients undergoing maxillofacial surgery, more so because of the concern of the sharing of the patient’s airway (Vas and Sawant, 2001). However, these patients require unconventional means for intubation. Blind nasal intubation or awake fiberoptic intubation are commonly used to secure their airways. However, both these measures are uncomfortable for the patient, and require a significant degree of cooperation from the patient (Batra and Mathew, 2005). Additionally, these techniques may cause airway trauma and require expertise in the field. Regional anaesthesia techniques have the advantage of avoiding the stress of awake intubation, at the start of the procedure, in these patients. We provided regional anaesthesia to 25 such patients, and all of them underwent uneventful surgery. In patients with mandibular fractures, pain, swelling, or spasm in the muscles causes acute trismus. Mandibular block in such patients decreases trismus and increases mouth opening, making it easier to intubate them (Heard et al, 2009). Patients receiving nerve blocks had less pain in the postoperative period than did those in the other group. They remained pain-free for longer after surgery. The amount of rescue analgesics used and the associated complications were less in the study group than in the general anaesthesia group. Previous studies have shown the efficacy of nerve blocks to reduce the postoperative pain significantly after elective orthognathic surgeries (Krishnan et al, 2008). Continuous mandibular nerve block has been advocated for post-surgery pain relief in mandible fracture cases (Singh and Bhardwaj, 2002). Recently, Perisanidis studied the use of ultrasound guided cervical plexus block for regional anaesthesia in oral and maxillofacial surgery (Perisanidis et al, 2012). This is a major benefit of providing regional anaesthesia to such patients. Another advantage of avoiding general anaesthesia is the lower incidence of PONV and sore throat after surgery. We observed a significantly higher incidence of PONV with general anaesthesia compared to regional anaesthesia and sedation. General anaesthesia continues to be associated with an unacceptably high incidence of PONV, in up to 20e30% of patients (Ku and Ong, 2003). The use of narcotics to provide adequate pain relief to patients undergoing surgery under general anaesthesia, contributes to the higher incidence of PONV in these patients. This might also be a cause of the delayed discharge after surgery (Ku and Ong, 2003). Patients receiving general anaesthesia with nasotracheal intubation also had a higher incidence of sore throat. This increased incidence of sore throat in the group II patients may be linked to endotracheal intubation. It is 12 times more likely to occur in patients with endotracheal intubation than in those managed with a face mask (Higgins et al, 2002). Succinylcholine, if used, as in difficult airway patients, also leads to a higher incidence of sore throat (Higgins et al, 2002). The occurrence of sore throat and PONV influences patient satisfaction in the postoperative period (Piper et al, 2008). In this study, patients in group I had fewer episodes of sore throat and PONV and were more satisfied with the anaesthetic technique than the other group. In addition to the nerve blocks, we sedated the patients with propofol during the surgery. This increased patient and surgeon comfort during the procedure (Leitch et al, 2003). In this study, the patients receiving regional anaesthesia were more comfortable than those receiving general anaesthesia. They did not have to face the stress of special airway manoeuvres and suffered from fewer postoperative complications. We did not find any significant difference in the surgeon’s satisfaction between the two groups. In a previous study, mandibular nerve blocks, used along with general anaesthesia, decreased the amount of blood loss during orthognathic surgery and provided a better surgical field than general anaesthesia alone (Espitalier et al, 2011).
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We found that patients in group I had less pain, fewer episodes of nausea and vomiting, and significantly less sore throat, all of which resulted in better satisfaction and earlier discharge from the PACU to the ward. The period of postoperative sedation was also longer in group II, resulting in a need for more watchful monitoring than in group I patients. 5. Conclusions Regional block with sedation is an excellent technique for maxillofacial surgery. It avoids airway manipulation in the conscious patient, provides better post-procedure analgesia and is associated with early discharge from the PACU with fewer complications. Regional block with sedation is a safe and reliable technique for maxillofacial surgery. Financial supports Nil. Conflict of interest The authors have no conflict of interest towards the preparation of this manuscript. Acknowledgement The first and the second authors have contributed equally towards the manuscript. Appendix A. Supplementary data Supplementary data related to this article can be found at http:// dx.doi.org/10.1016/j.jcms.2013.05.010. References Batra YK, Mathew PJ: Airway management with endotracheal intubation including awake intubation and blind intubation. Indian J Anaesth 49(4): 263e268, 2005
Boushra NN: Anaesthetic management of patients with sleep apnoea syndrome. Can J Anaesth 43(6): 599e616, 1996 Espitalier F, Remerand F, Dubost AF, Laffon M, Fusciardi J, Goga D: Mandibular nerve block can improve intraoperative inferior alveolar nerve visualization during sagittal split mandibular osteotomy. J Craniomaxillofac Surg 39(3): 164e168, 2011 Gajiwala KJ: Surgery of temporomandibular joint under local anaesthesia. Indian J Plast Surg 41(2): 175e182, 2008 Gundlach KK: Ankylosis of the temporomandibular joint. J Craniomaxillofac Surg 38(2): 122e130, 2010 Heard AM, Green RJ, Lacquiere DA, Sillifant P: The use of mandibular nerve block to predict safe anaesthetic induction in patients with acute trismus. Anaesthesia 64(11): 1196e1198, 2009 Higgins PP, Chung F, Mezei G: Postoperative sore throat after ambulatory surgery. Br J Anaesth 88(4): 582e584, 2002 Krishnan Radhika, Shivananda S, Uma Raman: Pre-emptive analgesia for elective maxillofacial surgery using 0.25% bupivacaine. Indian J Anesth 52(5): 556e561, 2008 Ku CM, Ong BC: Postoperative nausea and vomiting: a review of current literature. Singapore Med J 44(7): 366e374, 2003 Leitch JA, Sutcliffe N, Kenny GN: Patient-maintained sedation for oral surgery using a target-controlled infusion of propofol e a pilot study. Br Dent J 194: 35e43, 2003 Perisanidis C, Saranteas T, Kostopanagiotou G: Ultrasound-guided combined intermediate and deep cervical plexus nerve block for regional anaesthesia in oral and maxillofacial surgery. Dentomaxillofac Radiol, 2012 [Epub ahead of print] Piper SN, Röhm K, Boldt J, Kranke P, Maleck W, Seifert R, et al: Postoperative nausea and vomiting after surgery for prognathism: not only a question of patients’ comfort. A placebo-controlled comparison of dolasetron and droperidol. J Craniomaxillofac Surg 36(3): 173e179, 2008 Raval CB, Rashiduddin M: Airway management in patients with maxillofacial trauma e a retrospective study of 177 cases. Saudi J Anaesth 5(1): 9e14, 2011 Shah FR, Sharma KR, Hilloowalla RN, Karandikar AD: Anaesthetic considerations of temporomandibular joint ankylosis with obstructive sleep apnoea: a case report. J Indian Soc Pedod Prev Dent 20(1): 16e20, 2002 Singh B, Bhardwaj V: Continuous mandibular nerve block for pain relief. A report of two cases. Can J Anaesth 49(9): 951e953, 2002 van den Bergh B, Heymans MW, Duvekot F, Forouzanfar T: Treatment and complications of mandibular fractures: a 10-year analysis. J Craniomaxillofac Surg 40(4): e108ee111, 2012 Vas L, Sawant P: A review of anaesthetic technique in 15 paediatric patients with temporomandibular joint ankylosis. Paediatr Anaesth 11(2): 237e244, 2001 Walz C, Pape HD, Lenz M: Miniplate osteosynthesis of mandibular fracture in local anaesthesiaeindications and outcome in 316 patients. Fortschr Kiefer Gesichtschir 41: 133e135, 1996
Contents lists available at SciVerse ScienceDirect
Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com
Comparison of general anaesthesia versus regional anaesthesia with sedation in selected maxillofacial surgery: a randomized controlled trial Amit Rastogi a, Prakhar Gyanesh b, *, Surbhi Nisha c, Appurva Agarwal d, Priya Mishra e, Akhilesh Kumar Tiwari a a
SGPGI, Lucknow, India Global Hospital, Chennai, India Sardar Patel Institute of Medical and Dental Sciences, Lucknow, India d GSVM Medical College, Kanpur, India e Shine Dental Clinic, Lucknow, India b c
a r t i c l e i n f o
a b s t r a c t
Article history: Paper received 2 September 2012 Accepted 7 May 2013
Background: The airway is the foremost challenge in maxillofacial surgery. The major concerns are difficulty in managing the patient’s airway and sharing it between the anaesthetist and surgeons. General anaesthesia, with endotracheal intubation, is the commonly used technique for maxillofacial procedures. We assessed the efficacy and safety of a regional block with sedation technique in certain maxillofacial operations, specifically temporomandibular joint (TMJ) ankylosis and mandibular fracture cases, and compared it with conventional general anaesthesia. We compared the time to discharge from the post anaesthesia care unit (PACU) and the occurrence of side effects, as well as surgeon and patient satisfaction with the anaesthetic technique, between the two groups. Materials & Methods: We enrolled 50 patients of ASA grade 1 or 2, aged 15e50 years, scheduled for maxillofacial surgery (mandibular fracture or TMJ ankylosis). The patients were divided into two groups of 25 each, to receive sedation with a regional block with the use of a peripheral nerve stimulator in group I and general anaesthesia in group II. We observed haemodynamic parameters, intraoperative and postoperative complications and the amount of surgical bleeding in the two groups. Total anaesthesia time, patient and surgeon satisfaction, time to rescue analgesia, the number of rescue doses required, and the time to discharge from the PACU were compared. Results: The groups were comparable with respect to demographic profile, intraoperative haemodynamic parameters, surgical time, and amount of blood loss. Postoperative pain was assessed using the visual analogue score (VAS). Patients in group I had lower VAS scores after surgery and remained pain-free for longer than those in group II. The mean pain-free interval in group I was 159.12 43.95 min and in group II was 60.36 19.77 min (p < 0.005). Patients in group I required lower doses of rescue analgesia than those undergoing the surgery under general anaesthesia (p < 0.005). Patients receiving regional blocks also had fewer episodes of postoperative nausea and vomiting (p ¼ 0.005). These results led to earlier discharge of patients in group I from the PACU. Conclusions: Regional block with sedation is a safe alternative technique for patients undergoing surgery for mandible fracture or TMJ ankylosis, with clear advantages over general anaesthesia. Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Keywords: Regional anaesthesia Maxillofacial surgery sedation General anaesthesia Peripheral nerve stimulator
1. Introduction
* Corresponding author. Flat No F14, Casa Grande Riveria, Medavakkam, Chennai, India. Tel.: þ91 8874869249; fax: þ91 5224075803. E-mail addresses: [email protected], [email protected] (P. Gyanesh).
Mandibular fractures and temporomandibular joint (TMJ) ankylosis require special attention to the patient’s airway. These patients frequently present with difficulty in ventilation and intubation. Moreover, anaesthetists and surgeons have to share the patient’s airway during surgery (Vas and Sawant, 2001; Raval and
1010-5182/$ e see front matter Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jcms.2013.05.010
A. Rastogi et al. / Journal of Cranio-Maxillo-Facial Surgery 42 (2014) 250e254
Rashiduddin, 2011). General anaesthesia is the conventional way of managing these patients. This involves exposing the patients to the stress of ’awake’ airway manipulation and has its own set of postoperative problems (Batra and Mathew, 2005). Previous reports showed that surgery for TMJ ankylosis and mandibular fractures under regional anaesthesia can be safe and effective (Walz et al, 1996; Gajiwala, 2008). To our knowledge, no reported study has compared the efficacy and safety of general anaesthesia and regional anaesthesia with sedation in these cases. We propose that regional anaesthesia techniques may provide better postoperative analgesia, along with a decreased incidence of side effects, and thus earlier discharge from the postoperative care unit (PACU), than the use of general anaesthesia, in patients undergoing surgery for mandibular fractures or TMJ ankylosis. 2. Patients and Methods After approval from the institutional ethics committee, 50 patients between the ages of 15 and 50 years, undergoing surgery for mandibular fracture or TMJ ankylosis, were randomly allocated using computer-generated random numbers to two groups: Group I (regional block with sedation) and group II (general anaesthesia with endotracheal intubation), for the prospective study. Patients with an allergy to local anaesthetics, coagulation dysfunction, and ASA grade 3 were excluded. We also excluded patients with other traumatic fractures in addition to mandibular fractures, fractures of bilateral parasymphysis or condyle of the mandible and patients with significant obstructive sleep apnoea (OSA), who might have difficulty maintaining their airway in a supine position. We explained the entire procedure to the patient, and obtained their written consent. Patients in both the groups were uniformly premedicated with injection midazolam (0.03 mg/kg) and injection glycopyrrolate (0.004 mg/kg) intravenously. Preoperatively, both the groups received dexamethasone I.V. (0.08 mg/kg) to prevent airway oedema. Monitoring included five lead ECG, pulse oximetry, capnography, temperature and non-invasive blood pressure. We kept the difficult airway cart ready at all times. Once the patient was moved into the operating room (OR), baseline vital signs such as blood pressure, pulse rate, body temperature and oxygen saturation were recorded and induction was started according to the patient’s allotted group. We recorded the total time taken to induce the patient at the start of the procedure and the complete surgical time, and compared them between the groups. 2.1. Group I Patients in group I received mandibular and maxillary nerves blocks, with a solution made up of 14 ml of 0.5% bupivacaine, diluted in normal saline. The preauricular region was first infiltrated with 2 ml of the solution. The mandibular nerve was blocked by the coronoid approach, identifying the coronoid notch on the side of the block by opening or closing the mouth or by locating midpoint of the zygomatic process. A StimuplexR A (B.Braun Medical Pvt Ltd), 22G (50 mm) needle was inserted perpendicular to the median sagittal plane until it contacted the lateral pterygoid plate. It was then withdrawn slightly and reinserted, so that it moved inferiorly and posteriorly. After elicitation of paraesthesia and observing contractions of the masseter muscle with current value as low as 0.5 mA with StimuplexR HNS 12 (B.Braun Medical Pvt Ltd) nerve stimulator, 3e5 ml of the drug solution was injected with intermittent negative aspiration. The temporal region, auricle, external auditory meatus, TMJ, salivary glands, floor of the mouth, anterior two-thirds of the tongue, mandible, lower teeth, gingiva, buccal mucosa, and the inferior portion of the face was anesthetized following the injection.
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The needle was then withdrawn back to the level of the lateral pterygoid plate, directed superiorly and anteriorly, and advanced for 0.5e1 cm, until the development of paraesthesia over the maxillary nerve. Then, 5e10 ml of the local anaesthetic solution was injected to block the maxillary nerve. Use of the peripheral nerve stimulator allowed us to block the mandibular nerve with precision and after sedating the patient, thus providing greater patient comfort. The surgeon infiltrated the line of the incision with 2% adrenalized lignocaine solution (5e10 ml). After a bolus of propofol (40 mg if <60 kg or 60 mg if >60 kg), propofol infusion was started at the rate of 50 mg/kg/min and titrated to achieve and maintain a Modified Observer’s Assessment of Alertness/Sedation Scale (MOAA/S) of 2. A nasopharyngeal airway (number 8 for males and 7 for females) was inserted in one nostril, after proper lubrication with lignocaine jelly. An FG 8 catheter was inserted through the airway and connected to an oxygen source for insufflation with humidified oxygen. Surgery was started after confirming satisfactory surgical anaesthesia. In case of block failure, we planned to proceed as per the anaesthesia protocol for group II, and to exclude the patient from the study. Patients were moved to the PACU after surgery. 2.2. Group II Patients in this group received general anaesthesia with nasotracheal intubation. We assessed their airway preoperatively and decided on the technique of airway access. Patients with a mandibular fracture have trismus due to pain and generally have some mouth opening after induction of anaesthesia. In these patients, anaesthesia was induced with injection propofol (2.0 mg/kg), injection fentanyl (4 mg/kg). Considering the difficult airway in these patients, we used injection succinylcholine (1.5 mg/kg) to facilitate nasotracheal intubation. All patients with TMJ ankylosis underwent fiberoptic intubation while awake. The procedure was explained to them at the preanaesthetic check-up, and any anxiety was allayed. Airway anaesthesia for these patients was provided with lignocaine jelly and gargles, and transtracheal block, along with ‘spray as you go’ technique. Anaesthesia and muscle relaxation were maintained with intravenous propofol (50e150 mg/kg/minute) and vecuronium (0.1 mg/kg bolus followed by 1 mg every 30 min) and the patients’ lungs were ventilated with an oxygen-air mixture (1:1). All patients were extubated after reversal with neostigmine (0.05 mg/kg) and glycopyrrolate (0.01 mg/kg), using standard criteria of reversal (sustained head lift for 5 s and sustained handgrip for 5 s along with adequate spontaneous respiration). Patients were then moved to the PACU. Intramuscular diclofenac (75 mg) was given to both groups at the time of skin closure for postoperative analgesia. The severity of postoperative pain was measured and recorded using a 10-cm Visual Analogue Scale (VAS) score, where 0 ¼ no pain and 10 ¼ the worst imaginable pain. Intravenous paracetamol 1 g was used as rescue analgesia in the PACU if the VAS score was more than 3. Injection of tramadol (1.5 mg/kg intravenously) was given if the patients required another rescue before 4 h after paracetamol. All patients were studied for 24 h for the level of analgesia and the incidence of postoperative nausea and vomiting (PONV) and sore throat. Patients were monitored every 15 min in the PACU and every 4 h for the next 24 h in the ward. The Post Anaesthesia Discharge scoring System (PADSS score) was assessed by a doctor in the PACU and patients were moved when the PADDS score became >9. The length of PACU stay was recorded. We studied 25 patients in each group, which achieved a power of 80% for a difference of 30 min in the PACU length of stay at a
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significance level of 0.05. All results were analysed using SPSS 16 software. A p value of <0.05 was taken as significant with Bonferroni correction of the alpha value for multiple corrections. Demographic data were compared using the Chi-square test for categorical variables. Student t-test was used to compare the means of the two groups to assess the statistical significance of the difference in duration of PACU stay, the time until first rescue analgesia, and the number of rescue doses demanded. Incidence of sore throat and PONV was analysed using the Chi-square test while surgeon and patient satisfaction was analysed using the Kruskal Wallis test for non-parametric variables. 3. Results We evaluated 80 patients for enrolment in this study; 20 patients did not give consent, and were excluded and 10 patients suffering from multiple facial fractures and were also excluded. In total, 50 patients were enrolled and divided into groups by block randomization. The two groups were comparable with regard to surgery performed and demographic parameters (Table 1). Patients with mandible fractures underwent open reduction and internal fixation. Patients with TMJ ankylosis underwent gap arthroplasty or inferiorly based temporalis fascia or muscle fascia interpositional arthroplasty. There were no airway incidents in either group. There was no case of block failure. Both groups had comparable haemodynamic status, preoperatively and intraoperatively. There was less blood loss in the regional anaesthesia group, but this was not statistically significant (Table 2).
Table 3 Number of rescue analgesics required in the next 24 h.
Table 1 Type of surgery and demographic distribution. Group I Surgery (TMJ/Mand) Sex (M/F) Age (Mean S.D.) Weight (kg)
11/14 20/5 33.6 5.84 63.86 3.29
Total anaesthesia time was measured from the time the patient was taken into the OR until the patient was moved out of the OR. The anaesthesia time was significantly less in the regional group. The surgical times in the two groups were similar (Fig. 1). Postoperatively, the patients who received sedation and blocks remained more comfortable than those receiving general anaesthesia. They had better pain relief, suffered from fewer episodes of PONV and sore throat, and were discharged from the PACU earlier than those in the general anaesthesia group. We gave rescue analgesia to patients with a VAS score >3 in the postoperative period and noted the time until the first dose of the rescue analgesia. Patients receiving blocks had lower VAS scores in the postoperative period and remained pain-free for longer. There was a significant difference in the time to rescue analgesia between the two groups. The mean pain-free interval in group I was 159.12 min with a standard deviation of 43.95, while in group II it was 60.36 min with a standard deviation of 19.77 (p ¼ 0.001). We recorded and compared the number of rescue analgesia required by patients in the next 24 h. Patients receiving regional anaesthesia required fewer rescue analgesics; the difference was statistically significant (Table 3). Seven patients (28%) receiving general anaesthesia had a sore throat postoperatively, whereas none did in the other group. The incidence of PONV was also higher in those receiving general anaesthesia. There were 8 patients (32%) in group II with PONV whereas only a single patient in group I suffered from it. Both these parameters differed significantly between the two groups (Fig. 2). Patients were observed for 4 h for postoperative sedation using the MOAA/S scale. In group I, patients had excellent recovery from
Group II 8/17 18/7 32.16 4.13 59.56 4.63
p value .561 .742 .341 .156
Group I Group II
No. of rescue analgesics
p value
3.32 .557 5.92 .971
<.005
Table 2 Amount of surgical blood loss (ml) between groups.
Group I Group II
Amount of blood loss
p value
356 124.43 364 127.08
0.756
Fig. 2. Incidence of PONV and sore throat.
Fig. 1. Total surgical, anaesthesia and time taken to induce the patient.
Fig. 3. MOAA/S scoring in group I and group II in the postoperative period.
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sedation and after 30 min, patients were cooperative and welloriented. The two groups showed statistically significant difference in sedation level until 60 min after surgery (Fig. 3). Patients were discharged from the PACU based on the PADSS score. We measured the time to discharge from the PACU between the two groups and found it to be significantly different. The length of PACU stay was 35 7.1 min in the regional group while it was 93.80 12.5 min in the general anaesthesia group (p ¼ 0.004; Fig. 4). Patient and surgeon satisfaction were assessed postoperatively with the help of a four-grade questionnaire (poor, average, good, excellent). Patients in group I were comparatively more satisfied because they had an early discharge from the PACU and there was a very low incidence of PONV. However, there was no statistically significant difference when surgeon satisfaction was taken into account (Table 4). 4. Discussion We found that in patients undergoing surgery for mandible fracture or TMJ ankylosis, regional anaesthesia provided better postoperative pain relief than general anaesthesia, with lower incidences of PONV and sore throat. Patient satisfaction was also higher with regional anaesthesia than with general anaesthesia. Regional anaesthesia significantly reduced the time to discharge from the PACU, as assessed using PADSS score. The chief concern, when providing anaesthesia to patients undergoing orthognathic surgery, is the means of securing and maintaining each patient’s airway. While patients with a mandibular fracture have decreased mouth opening due to trismus, they may also have their maxilla and mandible wired together in the postoperative period (van den Bergh et al, 2012). TMJ ankylosis leads to facial deformity with retrognathia and these patients are difficult to ventilate and to intubate. Patients with TMJ ankylosis frequently have associated obstructive sleep apnoea (OSA), have difficulty in maintaining their airway when in a supine position, and are very sensitive to central depressant drugs used in general anaesthesia (Vas and Sawant, 2001; Gundlach, 2010; Raval and Rashiduddin, 2011). These patients should be extubated when they are fully awake, at the end of the procedure, and are prone to post-surgery desaturation (Boushra, 1996; Shah et al., 2002).
Fig. 4. Time to PACU discharge (minutes).
Table 4 Comparison of patient and surgeons’ satisfaction.
Patient satisfaction Surgeon satisfaction
Group Group Group Group
I II I II
Poor
Average
Good
Excellent
p value
0 0 0 0
1 3 1 1
10 15 12 13
14 7 12 11
0.03 0.79
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General anaesthesia with nasotracheal intubation is commonly used to anaesthetize patients undergoing maxillofacial surgery, more so because of the concern of the sharing of the patient’s airway (Vas and Sawant, 2001). However, these patients require unconventional means for intubation. Blind nasal intubation or awake fiberoptic intubation are commonly used to secure their airways. However, both these measures are uncomfortable for the patient, and require a significant degree of cooperation from the patient (Batra and Mathew, 2005). Additionally, these techniques may cause airway trauma and require expertise in the field. Regional anaesthesia techniques have the advantage of avoiding the stress of awake intubation, at the start of the procedure, in these patients. We provided regional anaesthesia to 25 such patients, and all of them underwent uneventful surgery. In patients with mandibular fractures, pain, swelling, or spasm in the muscles causes acute trismus. Mandibular block in such patients decreases trismus and increases mouth opening, making it easier to intubate them (Heard et al, 2009). Patients receiving nerve blocks had less pain in the postoperative period than did those in the other group. They remained pain-free for longer after surgery. The amount of rescue analgesics used and the associated complications were less in the study group than in the general anaesthesia group. Previous studies have shown the efficacy of nerve blocks to reduce the postoperative pain significantly after elective orthognathic surgeries (Krishnan et al, 2008). Continuous mandibular nerve block has been advocated for post-surgery pain relief in mandible fracture cases (Singh and Bhardwaj, 2002). Recently, Perisanidis studied the use of ultrasound guided cervical plexus block for regional anaesthesia in oral and maxillofacial surgery (Perisanidis et al, 2012). This is a major benefit of providing regional anaesthesia to such patients. Another advantage of avoiding general anaesthesia is the lower incidence of PONV and sore throat after surgery. We observed a significantly higher incidence of PONV with general anaesthesia compared to regional anaesthesia and sedation. General anaesthesia continues to be associated with an unacceptably high incidence of PONV, in up to 20e30% of patients (Ku and Ong, 2003). The use of narcotics to provide adequate pain relief to patients undergoing surgery under general anaesthesia, contributes to the higher incidence of PONV in these patients. This might also be a cause of the delayed discharge after surgery (Ku and Ong, 2003). Patients receiving general anaesthesia with nasotracheal intubation also had a higher incidence of sore throat. This increased incidence of sore throat in the group II patients may be linked to endotracheal intubation. It is 12 times more likely to occur in patients with endotracheal intubation than in those managed with a face mask (Higgins et al, 2002). Succinylcholine, if used, as in difficult airway patients, also leads to a higher incidence of sore throat (Higgins et al, 2002). The occurrence of sore throat and PONV influences patient satisfaction in the postoperative period (Piper et al, 2008). In this study, patients in group I had fewer episodes of sore throat and PONV and were more satisfied with the anaesthetic technique than the other group. In addition to the nerve blocks, we sedated the patients with propofol during the surgery. This increased patient and surgeon comfort during the procedure (Leitch et al, 2003). In this study, the patients receiving regional anaesthesia were more comfortable than those receiving general anaesthesia. They did not have to face the stress of special airway manoeuvres and suffered from fewer postoperative complications. We did not find any significant difference in the surgeon’s satisfaction between the two groups. In a previous study, mandibular nerve blocks, used along with general anaesthesia, decreased the amount of blood loss during orthognathic surgery and provided a better surgical field than general anaesthesia alone (Espitalier et al, 2011).
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We found that patients in group I had less pain, fewer episodes of nausea and vomiting, and significantly less sore throat, all of which resulted in better satisfaction and earlier discharge from the PACU to the ward. The period of postoperative sedation was also longer in group II, resulting in a need for more watchful monitoring than in group I patients. 5. Conclusions Regional block with sedation is an excellent technique for maxillofacial surgery. It avoids airway manipulation in the conscious patient, provides better post-procedure analgesia and is associated with early discharge from the PACU with fewer complications. Regional block with sedation is a safe and reliable technique for maxillofacial surgery. Financial supports Nil. Conflict of interest The authors have no conflict of interest towards the preparation of this manuscript. Acknowledgement The first and the second authors have contributed equally towards the manuscript. Appendix A. Supplementary data Supplementary data related to this article can be found at http:// dx.doi.org/10.1016/j.jcms.2013.05.010. References Batra YK, Mathew PJ: Airway management with endotracheal intubation including awake intubation and blind intubation. Indian J Anaesth 49(4): 263e268, 2005
Boushra NN: Anaesthetic management of patients with sleep apnoea syndrome. Can J Anaesth 43(6): 599e616, 1996 Espitalier F, Remerand F, Dubost AF, Laffon M, Fusciardi J, Goga D: Mandibular nerve block can improve intraoperative inferior alveolar nerve visualization during sagittal split mandibular osteotomy. J Craniomaxillofac Surg 39(3): 164e168, 2011 Gajiwala KJ: Surgery of temporomandibular joint under local anaesthesia. Indian J Plast Surg 41(2): 175e182, 2008 Gundlach KK: Ankylosis of the temporomandibular joint. J Craniomaxillofac Surg 38(2): 122e130, 2010 Heard AM, Green RJ, Lacquiere DA, Sillifant P: The use of mandibular nerve block to predict safe anaesthetic induction in patients with acute trismus. Anaesthesia 64(11): 1196e1198, 2009 Higgins PP, Chung F, Mezei G: Postoperative sore throat after ambulatory surgery. Br J Anaesth 88(4): 582e584, 2002 Krishnan Radhika, Shivananda S, Uma Raman: Pre-emptive analgesia for elective maxillofacial surgery using 0.25% bupivacaine. Indian J Anesth 52(5): 556e561, 2008 Ku CM, Ong BC: Postoperative nausea and vomiting: a review of current literature. Singapore Med J 44(7): 366e374, 2003 Leitch JA, Sutcliffe N, Kenny GN: Patient-maintained sedation for oral surgery using a target-controlled infusion of propofol e a pilot study. Br Dent J 194: 35e43, 2003 Perisanidis C, Saranteas T, Kostopanagiotou G: Ultrasound-guided combined intermediate and deep cervical plexus nerve block for regional anaesthesia in oral and maxillofacial surgery. Dentomaxillofac Radiol, 2012 [Epub ahead of print] Piper SN, Röhm K, Boldt J, Kranke P, Maleck W, Seifert R, et al: Postoperative nausea and vomiting after surgery for prognathism: not only a question of patients’ comfort. A placebo-controlled comparison of dolasetron and droperidol. J Craniomaxillofac Surg 36(3): 173e179, 2008 Raval CB, Rashiduddin M: Airway management in patients with maxillofacial trauma e a retrospective study of 177 cases. Saudi J Anaesth 5(1): 9e14, 2011 Shah FR, Sharma KR, Hilloowalla RN, Karandikar AD: Anaesthetic considerations of temporomandibular joint ankylosis with obstructive sleep apnoea: a case report. J Indian Soc Pedod Prev Dent 20(1): 16e20, 2002 Singh B, Bhardwaj V: Continuous mandibular nerve block for pain relief. A report of two cases. Can J Anaesth 49(9): 951e953, 2002 van den Bergh B, Heymans MW, Duvekot F, Forouzanfar T: Treatment and complications of mandibular fractures: a 10-year analysis. J Craniomaxillofac Surg 40(4): e108ee111, 2012 Vas L, Sawant P: A review of anaesthetic technique in 15 paediatric patients with temporomandibular joint ankylosis. Paediatr Anaesth 11(2): 237e244, 2001 Walz C, Pape HD, Lenz M: Miniplate osteosynthesis of mandibular fracture in local anaesthesiaeindications and outcome in 316 patients. Fortschr Kiefer Gesichtschir 41: 133e135, 1996